Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO)

February 14, 2024 updated by: Fundación EPIC

Concordance Between FFR and iFR for the Assessment of Intermediate Lesions in the Left Main Coronary Artery. A Prospective Validation of a Default Value for iFR (iLITRO Study)

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations.

Studies with a limited number of patients have shown that a value of FFR (Fractional Flow Reserve) above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The assessment of Left Main Coronary Artery (LMCA) lesions by means of coronary angiography renders serious limitations. In the case of intermediate stenoses (25-60%), invasive imaging tests, intravascular ultrasound (IVUS) or optical coherence tomography (OCT) or functional by determining the Fractional Flow Reserve (FFR), have been proposed to identify those patients who could benefit from revascularization.

Studies with a limited number of patients have shown that a value of FFR above 0.80 identify a low risk of events in case of not performing revascularization in patients with intermediate stenosis in the LMCA. Although iFR (Instant wave Free Ratio) has recently been found equivalent to FFR in assessing the prognosis of patients with intermediate lesions, the validation of the prognostic power of this index in patients with intermediate LMCA lesions has not been demonstrated, although it is used in clinical practice assuming the results in other locations of the lesions.

The demonstration of the prognostic utility of iFR in patients with LMCA intermediate lesions could have an important clinical impact and justify its systematic use for the treatment decision in these high-risk patients.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain, 02006
        • Hospital General Universitario de Albacete
      • Badajoz, Spain, 06080
        • Hospital Universitario de Badajoz
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol de Badalona
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 08041
        • Hospital De La Santa Creu I Sant Pau
      • Barcelona, Spain, 08028
        • Hospital Clínic i Provincial de Barcelona
      • Barcelona, Spain, 08908
        • Hospital Universitari Bellvitge
      • Cadiz, Spain, 11510
        • Hospital Universitario Puerto Real
      • Ciudad Real, Spain, 13005
        • Hospital General de Ciudad Real
      • Córdoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Gijón, Spain, 33203
        • Hospital Universitario de Cabueñes
      • Girona, Spain, 17007
        • Hospital Universitari Doctor Josep Trueta
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Huelva, Spain, 21005
        • Hospital General Juan Ramon Jimenez
      • León, Spain, 24080
        • Hospital de Leon
      • Lugo, Spain, 27003
        • Hospital Universitari Lucus Agusti
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos
      • Madrid, Spain, 28027
        • Clinica Universitaria de Navarra
      • Madrid, Spain, 28006
        • Hospital De La Princesa
      • Madrid, Spain, 28046
        • Hospital Universitario de La Paz
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen De La Victoria
      • Mérida, Spain, 06800
        • Hospital de Mérida
      • Oviedo, Spain, 33011
        • Hospital Universitario Central de Asturias
      • San Sebastián, Spain, 20014
        • Hospital Universitario de Donostia
      • Santander, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
      • Santiago De Compostela, Spain, 15706
        • Hospital Clinico Universitario de Santiago de Compostela
      • Tarragona, Spain, 43005
        • Hospital Universitari Joan Xxiii de Tarragona
      • Toledo, Spain, 45004
        • Hospital Universitario Virgen de La Salud
      • Valencia, Spain, 46026
        • Hospital Universitari I Politécnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Vigo, Spain, 36312
        • Hospital Universitario Alvaro Cunqueiro
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
    • Barcelona
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitari Mútua de Terrassa
    • Murcia
      • Cartagena, Murcia, Spain, 30202
        • Hospital General Universitario de Santa Lucia de Cartagena
      • El Palmar, Murcia, Spain, 30120
        • Hospital Clinico Universitario Virgen de la Arrixaca
    • Valencia
      • Castellón De La Plana, Valencia, Spain, 12004
        • Hospital General Universitario de Castellón
    • Vizcaya
      • Galdakao, Vizcaya, Spain, 48960
        • Hospital Galdakao-Usansolo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with intermediate stenosis of the LMCA will be included by coronary angiography (estimate visual 25-60%) in which a functional study is performed with pressure and calculation guidance of iFR and FFR with intravenous adenosine in perfusion to guide the indication of revascularization.

Description

Inclusion Criteria:

  • Patients with intermediate lesion in the LMCA (25-60% angiographic stenosis) by visual estimation) in which the realization of a study with guide of pressure for the determination of the iFR.
  • Patients aged ≥18 years.
  • Patients able of giving informed consent.

Exclusion Criteria:

  • Patients with indication for coronary surgery regardless of the significance of the LMCA lesion.
  • Patients with a LMCA lesion presenting with ulceration, dissection or thrombus.
  • Patients with previous arterial or venous graft lesion functioning in the territory irrigated by the LMCA (LMCA protected).
  • Patients with ACS (Acute Coronary Syndrome) with a potentially guilty lesion in the LMCA.
  • Patients unable to obtain informed consent.
  • Patients with known terminal illness that conditions a life expectancy less than 1 year.
  • Patients with hemodynamic instability with Killip III or IV class.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with intermediate lesions.
Patients with intermediate lesions (stenosis in angiography between 25% and 60%) in LMCA.
Other: Indication of revascularization
Device: iFR/FFR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment correlation between FFR>=0.80 and iFR >=0.89
Time Frame: 1 day
Efficacy and correlation of two invasive indexes of functional assessment by intracoronary pressure guidance in intermediate lesions of the LMCA with a cut-off point to defer the treatment of FFR> = 0.80 (with intravenous adenosine) and iFR > = 0.89. the LMCA.
1 day
Major Adverse Cardiac Events
Time Frame: 30 days
Composite of death, myocardial infarction, unplanned revascularisation
30 days
Major Adverse Cardiac Events
Time Frame: 1 year
Composite of death, myocardial infarction, unplanned revascularisation
1 year
Major Adverse Cardiac Events
Time Frame: 5 years
Composite of death, myocardial infarction, unplanned revascularisation
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment correlation between iFR and IVUS
Time Frame: 5 years
Assessment correlation between iFR and IVUS derived minimal luminal area
5 years
Death (all cause)
Time Frame: 30 days, 1 and 5 years
Death (all cause)
30 days, 1 and 5 years
Death (cardiovascular)
Time Frame: 30 days, 1 and 5 years
Death (cardiovascular)
30 days, 1 and 5 years
Non-fatal Myocardial Infarction
Time Frame: 30 days, 1 and 5 years
Non-fatal Myocardial Infarction
30 days, 1 and 5 years
Non-fatal Myocardial Infarction related to the LMCA lesion
Time Frame: 30 days, 1 and 5 years
Non-fatal Myocardial Infarction related to the LMCA lesion
30 days, 1 and 5 years
Revascularization
Time Frame: 30 days, 1 and 5 years
Revascularization
30 days, 1 and 5 years
Revascularization of the target lesion
Time Frame: 30 days, 1 and 5 years
Revascularization of the target lesion
30 days, 1 and 5 years
Myocardial Infarction related to target lesion revascularization
Time Frame: 30 days, 1 and 5 years
Myocardial Infarction related to target lesion revascularization
30 days, 1 and 5 years
Stent Thrombosis in the target lesion revascularization
Time Frame: 30 days, 1 and 5 years
Stent Thrombosis in the target lesion revascularization
30 days, 1 and 5 years
Restenosis of the stent in target lesion
Time Frame: 30 days, 1 and 5 years
Restenosis of the stent in target lesion
30 days, 1 and 5 years
New revascularization of the target lesion
Time Frame: 30 days, 1 and 5 years
New revascularization of the target lesion
30 days, 1 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Investigators

  • Principal Investigator: José María de la Torre, PhD, MD, Hospital Universitario Marqués de Valdecilla
  • Principal Investigator: Oriol Rodríguez Leor, PhD, MD, Germans Trias I Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2019

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

December 2, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iLITRO EPIC-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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